FDA Adverse Event
Other
Summary report: N
SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE
MDR report key: 1592447
·
Received January 27, 2010
Report
- Report Number
- 9610726-2010-00036
- Event Type
- Other
- Date Received
- January 27, 2010
- Date of Event
- January 12, 2010
- Report Date
- January 12, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SIMPLEX P WITH TOBRAMYCIN WAS USED IN A PRIMARY TOTAL KNEE." THIS IS OFF LABEL USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MJQ055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |